Reminder-enhanced Incentive Spirometry Evaluation

The purpose of this study is to test whether automatic reminders with a light and a soft sound help patients improve deep breathing exercises after surgery. These breathing exercises are routinely done with the help of a plastic device that you attach to your mouth and you take a deep breath. These exercises are routinely recommended after major surgery to improve the oxygen level in your blood and reduce other respiratory problems.

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Key information

Conditions

Hypoxemia Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The goal of this project is to evaluate whether automatic reminders increase incentive spirometry performance (IS) and reduce hypoxemia during the first three postoperative days after inpatient non-cardiac surgery in patients with a preoperative ARISCAT risk score ≥26.

This three-center pilot study will first test the effectiveness of automatic IS reminders, compared to no reminders, on the quality of performance for three postoperative days after inpatient non-cardiac surgery. Then we will estimate the effect size of IS reminders on postoperative hypoxemia and other complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

≥18 years
Planned non-cardiac surgery under general anesthesia with at least one night of hospitalization expected
Preoperative ARISCAT risk score ≥26
Signed informed consent

Exclusion criteria

Inability to perform IS due to refusal, cognitive impairment, neuromuscular weakness, anatomical, or any other reasons (e.g., tracheotomy, oral surgery, unable to hold incentive spirometer)
Have a severe hearing or visual acuity impairment that prevents them from hearing or seeing the audible and visual IS reminders
Are part of a vulnerable population (minors, pregnant, prisoners)
Lack of informed consent

Treatment and study plan

Alarms ON

Device

Alarms are turned ON. The alarms include a dim light and soft buzz every twenty minutes during waking hours.

Primary outcomes

Median IS breaths per hour

Time frame: Post-Anesthesia Care Unit (PACU) admission to postoperative day 3 (POD3)

Median adequate IS breaths per hour within eligible hours of all patients in each reminder group

Other outcomes

Hypoxemia

Time frame: From post-anesthesia care unit (PACU) admission to postoperative day 3 (POD3)

Hypoxemia will be calculated using the trapezoidal rule when PaO₂/FiO₂ < 300. The total time with hypoxemia for each POD will be observed using the area-under-curve (AUC); i.e., the use of the area under the oxygen saturation curve

Study contacts

Contact information is provided by the study sponsor or research team.

Emily G Helmer, BA

CONTACT

[email protected]

(303) 724-2938

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Reminder-enhanced Incentive Spirometry Evaluation (RISE)

Acronym: RISE

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2029
First posted: Jul 27, 2026
Registry last updated: Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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